Kornimate/medical-research-clean huggingface dataset:
colesevelam, lipids and sugars, south asian canadian trial

Conditions: Dyslipidemia

Summary: to evaluate the effect of colesevelam on ldl levels and a1c in high-risk , dysglycemic south asians (with diabetes, and/or with cad and concomitant metabolic syndrome) whose ldl remains above target despite optimal statin use.

this is a prospective, non-controlled, open label, multicenter trial of colesevelam in canadian south asian adults at high cardiovascular risk. 1. 15-20 clinical sites from ontario, quebec, manitoba and british columbia will be selected from ccrn's network of primary care physicians and cardiologists to identify patients having stable type 2 diabetes or documented stable cad with metabolic syndrome who are on maximally tolerated statin therapy, with ldl \>2.0 mmol/l or non-hdl \> 2.6 mmol/l. 2. following informed consent, patients will be screened at baseline for hba1c, fasting blood glucose, lipid profile, renal function and liver enzymes. 3. baseline demographics, cad and diabetes documentation and concurrent drug therapy will be collected. 4. 250 eligible patients will receive a physician prescription of colesevelam (lodalis) 625 mg tablets (3 tablets taken twice daily) for 24 weeks. 5. physicians will be requested not to change lipid or diabetes therapy over the 24 week course of the trial. 6. patients will be contacted at 2 and 12 weeks (visit 3 and 4) via a phone call to assess adherence to the prescribed therapy, review other concurrent medications and assess for any adverse events. 7. the week 24 visit (study visit 5) will include collection of fasting blood work as per screening visit, review of concurrent drug therapy and a final assessment for any adverse events.

Eligibility criteria:
inclusion criteria: * individuals of south asian ethnicity; self-declared, at least 3 of 4 grandparents born in a south asian country (i.e. india, pakistan, bangladesh, sri lanka, nepal and bhutan) * either diabetes, or coronary artery disease with metabolic syndrome * currently receiving maximally tolerated dose of statin therapy (at least atorvastatin 20 mg or rosuvastatin 10 mg) * ldl \>2.0 mmol/l or non-hdl \>2.6 mmol/l * patient is willing to provide written consent * age ≥ 18 years exclusion criteria: * receiving lipid-lowering agents, other than statins or ezetimibe * any changes made to current lipid lowering therapy in the last 12 weeks * uncontrolled diabetes (hba1c \>0.10) * tg \> 5.0 mmol/l * significant hepatic or renal disease (alt \> 2x uln or egfr \< 30 ml/min/1.73 m²) * ongoing participation in any randomized clinical trial

Keywords: ldl cholesterol a1c high risk south asians colesevelam
venous ulcer: endovenous radiofrequency treatment trial

Conditions: Varicose Ulcer; Varicose Veins of Lower Limb; Saphenous Vein Injury

Summary: the aim of this study is to analyze the effect of intravenous therapy with radiofrequency for superficial and perforating venous insufficiency versus compression therapy with multilayer banding in patients with active venous ulcer. this is a controlled, randomized prospective clinical trial. people with venous ulcers and primary venous insufficiency in superficial and perforating venous system will be studied. participants will be divided into two experimental groups: compression therapy alone, and compression therapy associated with superficial and perforating venous system ablation. clinical aspects, improvement in patients' quality of life and interventions cost-effectiveness will be analyzed. patients will be followed for 12 months after ulcer healing.


Eligibility criteria:
inclusion criteria: * age between 18 and 80 years old * venous ulcer appeared at least 4 weeks, bellow knee * ankle-brachial index more than 0.9 * saphenous veins insufficiency plus perforating veins reflux * saphenous vein diameter between 5 mm and 12 mm * absence of saphenous veins thrombophlebitis * absence of personal history of venous deep thrombosis * absence of ultrasound evidence of actual or previous venous deep thrombosis * absence of severe ankle anquilosis exclusion criteria: * unable to provide informed consent * unable to receive surgical intervention due to severe clinical condition

Keywords: varicose ulcer venous ulcer radiofrequency ablation perforating veins insufficiency varicose veins treatment
knee pressure stimuli on quadriceps strength in knee osteoarthritis

Conditions: Knee Osteoarthritis; Muscle Weakness

Summary: the study aims at investigating the effects of a periarticular knee pressure stimulation on quadriceps strength and neuromuscular activity in subjects with knee ostearthritis. twenty-five patients with end-stage knee osteoarthritis and and twenty-five age-matched healthy subjects will be enrolled. all participants will be asked to performed isometric maximal voluntary knee extension tasks with three different pressure stimuli in terms of intensity (0 mmhg, 60 mmhg, 120 mmhg) around the knee using a sphygmomanometer. peak force and root-mean-square peak of rectus femoris, vastus medialis, and vastus lateralis will be collected.

the study aimed at assessing the effects of a periarticular pressure stimulation of the knee joint on quadriceps strength and neuromuscular activity in patients with end-stage knee osteoarthritis. twenty-five patients with end-stage knee osteoarthritis and and twenty-five age-matched healthy subjects will be enrolled. participants will seat on a dynamometer chair (bar, otbioelettronica, italy) with hips and knees at 90 degrees and 30 degrees of flexion, respectively. participants will perform six maximal voluntary knee extension tasks with three different pressure stimuli in terms of intensity (0 mmhg, 60 mmhg, 120 mmhg) around the knee using a sphygmomanometer. two maximum voluntary contractions interspaced by 3 minutes of rest will be performed for each pressure level, and the peak force (n) will be collected and normalized for the highest value during the three conditions. moreover, root-mean-square peak (rms-peak) of rectus femoris, vastus medialis, and vastus lateralis will be recorded using bipolar surface electromyography electrodes (freeemg, bts, italy). the rms-peak of each muscle will be normalized for its highest value among the three conditions (nrms-peak) and used as index of neuromuscular activity.

Eligibility criteria:
inclusion criteria: * end-stage knee osteoarthritis * age between 40 and 80 years * at least 0-90° of knee range of motion along the sagittal plane exclusion criteria: * cognitive impairments or psychiatric disorders * concomitant neurological, orthopedic, cardiovascular disorders * lower limb orthopedic surgery or traumatic events in the previous year
effect of exercise intervention on body composition and quality of life in post-bariatric surgery patients

Conditions: Exercise

Summary: this study will investigate the effectiveness of a rehabilitation program in improving body composition, and quality of life in patients with bariatric surgery in taiwan. hypothesis: 1. the body composition in exercise group is significant improving than control group at 1 weeks, 1st, 2nd, and 3rd month. 2. the quality of life in exercise group is significant improving than control group at 1 weeks, 1st, 2nd, and 3rd month.

this study will investigate the effectiveness of a rehabilitation program in improving body composition, and quality of life in patients with bariatric surgery in taiwan.

Eligibility criteria:
inclusion criteria: 1. after the research purpose is stated, the subject agrees and is willing to participate in the researcher and is willing to sign a written consent form. 2. 20-60 years old, with clear consciousness, can communicate with the mandarin and taiwanese, and are willing to conduct this research. 3. body mass index according to the asia pacific implementation of bariatric surgery indications, bmi≧37 kg/m2 or bmi≧32 kg/m2 combined with metabolic diseases caused by obesity, such as cardiovascular disease, type 2 diabetes, obstructive sleep apnea(osa), nonalcoholic fatty liver, and degenerative arthritis. 4. patients with morbid obesity undergoing laparoscopic gastric sleeve resection or laparoscopic gastric bypass surgery. 5. explain how the smart phone application (google fit) and (68 heart rate monitor) are used, and the patient or family member can be operated after returning home. exclusion criteria: 1. after the attending physician evaluates,medical order presentation a person who cannot perform exercise prescriptions. 2. lower limb limb disorders or amputations cannot coordinate with exercise prescription. 3. poorly controlled cardiovascular diseases such as arrhythmia, angina, heart failure,myocardial infarction, and chest pain during activities or rest in the past three months. 4. patients with poor diabetes control, glycosylated hemoglobin (hba1c) \> 9%, with eye lesions or neuropathy. 5. those with poor blood pressure control, systolic blood pressure greater than 160mmhg or diastolic blood pressure greater than 100mmhg when quiet. 6. heart rate is greater than 100bpm when quiet.

Keywords: bariatric surgery body composition morbid obesity quality of life walking exercise
evaluation of the effect of epitomee device on gastric emptying rate in healthy subjects

Conditions: Overweight and Obesity

Summary: evaluation of the effect of epitomee device on gastric emptying rate in healthy subjects

the participants will be enrolled in one investigational site. subjects meeting eligibility criteria will undergo a gastric emptying test using gastric scintigraphy before any treatment (baseline). following the scintigraphy, the subjects will receive tulip device treatment - 2 capsules/day. after repeated capsule intake for either 4 or 11 or 28 days, the subjects will undergo additional gastric emptying test with a capsule intake prior to the test meal.

Eligibility criteria:
inclusion criteria: 1. 21 ≤ age \<65 years 2. 20 \< bmi ≤ 40 kg/m2 3. healthy subject 4. subject is able and willing to give informed consent 5. subject is able and willing to participate in the study and follow protocol procedures exclusion criteria: 1. significant swallowing disorders or difficulty swallowing 2. suspected gi strictures, fistulas or other gi track obstructions 3. crohn's disease or diverticulosis 4. recent gi surgery 5. history of long-standing undigested food in the stomach 6. known ulcer disease 7. organic disease associated with gastroparesis such a parkinson's disease, cerebrovascular accident, neuromuscular disease or eating disorder 8. presence of a gastrostomy tube or gastric outlet obstruction 9. history or evidence of any active liver disease 10. allergy to eggs 11. treatment with anticholinergic or prokinetic agents 12. treatment with proton-pump inhibitors 13. hypothyroidism, hyperthyroidism or taking thyroid hormone deficiency drugs (such as l-thyroxine) 14. prediabetes or diabetes 15. any history or evidence of significant cardiac, renal, neurologic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease or symptom which in the judgment of the investigator would interfere with the study or confound the results 16. pregnancy or breastfeeding 17. currently participating in an ongoing clinical study
a medium chain triglyceride intervention for patients with alzheimer disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to determine safety, tolerability, and pharmacokinetics/dynamics of a ketogenic dietary supplement containing medium chain triglycerides (mcts) in patients with alzheimer disease (ad). novel imaging and laboratory biomarkers in response to this intervention will also be explored.


Eligibility criteria:
inclusion criteria: * diagnosis of mild-moderate alzheimer disease (ad) * mini-mental state examination (mmse) 16-26 * study partner available who has frequent contact with the participant * good visual and auditory acuity for neuropsychological testing * education including completion of at least six grades * must read and speak english fluently * antidepressants permitted, if stable for 4 weeks prior to screening (and participant is not currently depressed and does not have a history of major depression within the past 1 year) * cholinesterase inhibitors permitted, if stable for 12 weeks prior to screening exclusion criteria: * any significant neurologic disease other than ad * history of diabetes mellitus type i or ii * any contraindications to mri or pet studies * major depression, bipolar disorder as described within the past 1 year. * history of schizophrenia * history of alcohol or substance abuse or dependence within the past 2 years * any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol * current use of specific psychoactive medications * investigational amyloid lowering therapies are prohibited two months prior to screening and for the duration of the trial. other investigational agents are prohibited one month prior to screening and for the duration of the trial. * history of brain cancer

Keywords: medium chain triglyceride mct coconut oil mri pet ketones
placebo controlled study in subjects with relapsing forms of ms to evaluate the safety, tolerability and effects of cdp323

Conditions: Multiple Sclerosis

Summary: the objective of the study is to evaluate the effect, safety and tolerability of cdp323 in patients with relapsing forms of multiple sclerosis


Eligibility criteria:
inclusion criteria: * relapsing form of ms * screening edss score 0 - 5.5, inclusive * at least one clinical relapse in the 12 months before screening * active disease, defined by set of mri activity criteria * failed prior treatment with beta-interferons or glatiramer acetate exclusion criteria: * signs of silent infections, including positive tests for hiv1, hiv2 or hepatitis b or hepatitis c or tuberculosis * known allergy to gadolinium-dtpa, and/or ingredients of the study drug formulation * pre-treatment with immunosuppressive or immunomodulatory drugs prior to screening within certain time frames

Keywords: cdp323 relapsing multiple sclerosis magnetic resonance imaging oral compound ms
discharge education in diabetic surgical patients

Conditions: To Examine the Effects of Diabetes-based Personalised Discharge Education Given to Diabetic Surgical Patients on Satisfaction; To Examine the Effects of Diabetes-based Personalised Discharge Education Given to Diabetic Surgical Patients on Diabetes Empowerment

Summary: in the literature, it is seen that the discharge education given to patients with diabetes is especially focused on the effects of blood glucose control and self-efficacy, and there is no study examining the effects of discharge education on diabetes empowerment with a more general perspective in diabetes patients in surgical processes. in this context, the study was designed to examine the effects of diabetes-based personalised discharge education given to surgical patients on satisfaction and diabetes empowerment.

he population of the study consists of patients diagnosed with diabetes and undergoing surgery in the surgical and mixed service of izzet baysal training and research hospital. the sample number of the experimental study, which was planned to be carried out between january 2025 and december 2026, was planned to include 100 patients with 0.05 error, 0.95 confidence interval and 0.85 power in the calculation made in the gpower statistical programme based on previous studies. considering that patients could leave the study for other reasons, it was decided to carry out the study by randomisation with 110 patients, which is 10% more. discharge training satisfaction scale for surgical patients: it is a scale developed to measure the satisfaction of surgical patients with discharge training. it consists of 21 items in a five-point likert structure and has been evaluated as a valid and reliable tool for measuring patient satisfaction. the scale covers factors such as discharge process, personal information, home care, infection monitoring and controls. the cronbach α reliability coefficient was found to be 0.91, indicating that the scale is highly reliable diabetes empowerment scale: it is a 5-point likert-type scale consisting of 8 items. turkish validity and reliability was carried out by jahanpeyma et al. in 2020

Eligibility criteria:
inclusion criteria: * he's had an operation, * over 18 years old, * diagnosed with diabetes, * conscious patients returning to the clinic after surgery, not intubated exclusion criteria: * he's unconscious, * referral to intensive care, * patients who do not agree to participate in the study will be excluded from the study.

Keywords: diabetes empowerment satisfaction
study of the pharmacodynamic activity of p-321 ophthalmic solution compared to placebo in subjects with dry eye disease

Conditions: Dry Eye Disease

Summary: the purpose of this phase 2a study is to assess changes in tear volume by the non-invasive techniques ultra high resolution optical coherence tomography (uhr-oct) following the administration of p-321 ophthalmic solution or placebo in subjects with tear deficient dry eye disease.

this is a single-center, randomized, cross-over placebo controlled study to evaluate the changes in tear volume by p-321 ophthalmic solution and placebo. the study will enroll subjects with tear deficient dry eye disease to receive sequentially one of two treatment sequences: p-321 ophthalmic solution then placebo or placebo then p-321. the study will consist of two phases: in each phase, subjects will be treated with p-321 ophthalmic solution under the same study design. approximately twenty-four eligible subjects will complete the study with approximately 8 subjects participating in phase 1 and the remainder of the 24 subjects participating in the phase 2. decisions on the dose to be used in phase 2 will be made based on phase 1 data. the study will consist of three study visits: a screening visit (visit 1), and two treatment visits (visit 2 and visit 3). the primary and secondary outcome measures will be assessed at each treatment visit. safety assessments include adverse events (aes).

Eligibility criteria:
inclusion criteria: 1. provide written informed consent 2. male or female subjects aged 18 to 80 years 3. have a history of predominantly tear-deficient dry eye of mild to moderate severity, supported by a previous clinical diagnosis 4. have normal lid anatomy 5. subjects must: 1. remain on current medications for the duration of the study and have been on the current medication regimen at least during the past 28 days exclusion criteria: 1. have undergone refractive eye surgery in either eye during the past 12 months 2. have undergone uncomplicated cataract surgery in either eye during the past 3 months 3. have undergone previous eyelid surgery in either eye (external blepharoplasty, not resulting in exposure or abnormal blinking is allowed) 4. have undergone botulinum toxin (botoxth1 or equivalent) injection in the periocular area within 3 months prior to visit 1 5. subjects that have a systemic, multi-organ disease requiring active medical or surgical treatment are excluded with the exception of subjects with ss or gvhd 6. have punctal plugs, punctal occlusion, history of nasolacrimal duct obstruction or wear scleral lens. 7. past or present exposure keratopathy, neurotrophic keratopathy, lagophthalmos, or trichiasis
niti car27 (colonring) compression anastomosis in colorectal surgery

Conditions: Colonic Neoplasms; Rectal Neoplasms; Diverticulitis; Inflammatory Bowel Diseases; Rectal Prolapse

Summary: after resection of diseased segments of the large intestine, the continuity of the intestine has to be restored. this can be done by suturing or with so called stapling devices. in addition since 2 centuries compression rings are used to connect the intestine after resection. the niticar27 device is a novel compression anastomosis device. the investigators want to prove if this novel device can be compared to commonly used stapling devices concerning anastomotic leakage, bleeding and stenosis.


Eligibility criteria:
inclusion criteria: * benign and malign lesions of the colon and rectum exclusion criteria: * advanced peritonitis (putrid, feculent)

Keywords: anastomotic leakage bleeding from the anastomotic region anastomotic stenosis
neuroanatomy of reading in congenital deafness.

Conditions: Congenital Deafness

Summary: the aim of the research is to investigate phonological processing in deafness and to examine its influence on the neuroanatomy of reading.the basic hypothesis is that insofar as the ability to read is closely related to the ability to segment and represent speech units, the neuroanatomy of reading in deaf would be different from the one of hearing readers.


Eligibility criteria:
inclusion criteria: * adult * full education exclusion criteria: * reading impairment * fmri

Keywords: neuropsychology fmri reading phonology deafness
functional recovery from acute respiratory distress syndrome (ards) due to covid-19: influence of socio-economic status

Conditions: Covid19; ARDS; Functional Recovery

Summary: in this study, the investigators are attempting to evaluate the influence of socio-economic factors on the functional recovery (physical and psychological) of patients who developed ards after a covid-19 infection, with the aim of offering personalized medical and social follow-up and support measures in order to avoid medium- and long-term complications, which can result in handicaps, reduced quality of life, and a higher risk of death.


Eligibility criteria:
inclusion criteria: * inpatient in icu for pcr-proven sars-voc-2 infection regardless of specimen type * patient who received a chest ct scan in the initial phase of management (either just before or during hospitalization in the intensive care unit) * patient who has received invasive or non-invasive ventilatory support, or humidified and heated high-flow oxygen (hfo). * ards meeting the criteria of the 2012 berlin definition. for patients who have received only hfo, a flow rate at least equal to 50l/minute with a fio2 strictly greater than 50% with a pao2/fio2 ratio less than or equal to 200 will be required for inclusion. * patient who gave oral consent after being informed about the conduct of this study. exclusion criteria: * patient with limited autonomy prior to hospitalization in limited intensive care unit: walking distance of less than 50 meters, who classification status 3 and 4. * patient with a history of chronic respiratory failure as defined by the use of long-term oxygen therapy or non-invasive home ventilation, excluding patients with sas and/or hypoventilation obesity syndrome. * patient with a history of central or peripheral neurological conditions limiting the patient's motor autonomy and the performance on gait tests or pulmonary function tests * patient refusing to participate * patient \< 18 years of age * patient not affiliated or not benefiting from national health insurance * patient under guardianship, curatorship or protected adult * patient unable to understand and consent to the research protocol secondary exclusion criteria * patient not showing up for visit at m6 * patients who have not had all the examinations necessary to evaluate the main endpoint (spirometry, dlco, tm6 and ct)